Anxiety, Depression
Conditions
Brief summary
This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.
Interventions
BEHAVIORALDigital Cognitive Behavioral Therapy
digital cognitive behavioral therapy app
BEHAVIORALHealth Education
traditional on-line health education app
DRUGTAU
treatment as usual
Sponsors
Adai Technology (Beijing) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient. 2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization. 3. Age ≥ 18 and ≤ 65 years, regardless of gender. 4. Understands the trial and signs the informed consent form.
Exclusion criteria
1. Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions. 2. History of substance and/or alcohol abuse within the past year. 3. Significant risk of suicide (MADRS item 10 score = 4). 4. Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment. 5. Inability to use a smartphone. 6. Deemed unsuitable for participation by the researcher.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months | Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PHQ-9 (Patient Health Questionnaire-9) | baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months | PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms. |
| GAD-7 (Generalized Anxiety Disorder-7) | baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months | GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms. |
| Snaith-Hamilton Pleasure Scale (SHAPS) | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months | Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure). |
| Rumination Response Scale (RRS) | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months | Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination. |
| Pittsburgh Sleep Quality Index (PSQI) | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months | Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality. |
Countries
China
Contacts
Primary ContactLiqun Zhang
Outcome results
None listed